GE Healthcare has announced the startup of the contrast medicines production

| By | GE Healthcare, Localization, Pharmstandard

This project will contribute to the development of the Russian pharmaceutical industry and also will meet the challenges of the state program “Pharma 2020”, oriented to increase the proportion of the essential medicines, manufactured in Russia.

Localizied contrast medicines Visipaque® (INN Iodixanol), Omnipaque® (INN Iohexol) and Omniscan® (INN gadodiamide) are used for diagnostics of various organs and systems disorders, including cardiovascular, nervous diseases and cancer. In addition, iodine-containing Omnipaque® and Vizipaque® are used for visualization during endovascular interventions.

The packing and release quality control will be organized within the startup of the first phase of the project on the production site of OJSC “Pharmstandart-Ufavita” in Ufa, certified in compliance with international standards of Good Manufacturing Practice (GMP). Earlier the contrast medicines were imported to Russia from GE Healthcare manufacturing plant in Ireland. It is planned that the first batches of medicines, released by OJSC “Pharmstandart-Ufavita”, will be available on the market at the end of 2016.

The second stage involves the extension of localization of the GE Healthcare contrast  medicines and the final product manufacturing in Russia. As part of the project it is planned to purchase the production facilities, to transfer the technology and analytical quality control methods, to trainee production and laboratory staff as well as to conduct stability studies of all three medicines at the OJSC “Pharmstandart-Ufavita” site.

Andrey Demurin, Head of biotech facilities and contrast agents GE Healthcare Russia/CIS has noted:

“We are proud to contribute to the development of the Russian pharmaceutical industry and the Russian health care in general together with the company” Pharmstandart”. The innovative technologies, knowledge and experience of GE in the field of contrast agents will allow to organize domestic production of medicines for Russian patients in accordance with the highest international standards. ”

Grigory Potapov, CEO of PJSC “Pharmstandart”:

“We are pleased to start cooperation with GE Healthcarecompany in the field of localization of the core portfolio of contrast agents, two of which are inscribed to the list of vital and essential medicines. Our production meets the highest international standards and our expertise will ensure the production of finished forms of our partners on high-quality level. Localization of production has become one of the key elements of our strategy, which fits well into the public policy and import substitution state strategy “Pharma 2020”.

GMP news
Pharmaceutical industry News and events. Technology transfer and contract manufacturing of medicines.